First off, the movie, The Haunting… Not a great movie by any means (it holds a rating of 17% on Rotten Tomatoes), and even the awesome cast couldn't save it.
|The cast, searching desperately for a sensical plot...|
Research Protocol Review
Dr. David Marrow discusses his project with his department chair, who insists that he can't conduct the study ethically. But he ultimately lets Dr. Marrow do what he wants and shrugs as if to say, "But hey, give it a try and see how it turns out." How would that conversation have ended in real life? The department chair would have concluded his comment on ethics with, "but we'll have to let the IRB sort it out. File the paperwork and you should have a decision in a couple of months."
|Let's see, I'm bribing emotionally unstable insomniacs with a sizable salary and free room-and-board to come to a weird old house that I'm going to trick them into thinking is haunted. That should qualify for expedited review, right?|
Did he get the IRB's approval of the text of his ad before putting it in the paper? And is the newspaper staff member handling the call inquires on the IRB paperwork (since he or she will be speaking with potential participants)? If not, better file an amendment first.
After filing his amendment and getting the staff member at the newspaper to complete the necessary ethics trainings, Dr. Marrow can again proceed with recruiting participants.
The Study Itself
Once he has them, he invites them to the house where they will begin the study. All good for now. But what's next in the study procedure? Signing consent forms! What fun. Oh, and since he's collecting information about people's sleeping patterns, medical diagnoses of insomnia, etc., he better also have them sign a HIPAA authorization too.
|And on page 20 of the consent form, you'll see that you can stop participating at any time without penalty. Directly below that, see the note about the gatekeeper chaining us in every night.|
So now he has three consenting, HIPAA-authorizing participants. He can go on with the study, which also involves the house staff giving the participants additional information about the house being haunted.
|Wait, I didn't see anything about confederates in your study paperwork. Better file another amendment and complete protocol deviation forms for the three participants.|
But then things go horribly wrong. It turns out the house really is haunted and the people are actually in danger. What does the IRB say? The IRB requires researchers to report any adverse events (harm) or serious adverse events (injury or even death) caused by the study. Both require forms to be filed with the IRB, and the IRB must then decide if the study can continue safely.
This would be a serious adverse event.
Basically, all of these protections are in place for a reason. Informed consent means the participants know what they are in for - they may not know the true purpose of the study (because deception is allowed) but they have to know what they will be asked to do in the study and potential harms that may result. Participants also have to be allowed to leave the study at any time if they wish. The IRB continues to oversee studies and steps in if things turn out to be more harmful than originally thought.
|Somebody find the chain cutters...|
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